/~r > (Amendmenl IT to H. a. I. Order _7t;> (Effective April 20, 1943) United States Department of Agriculture AGRICULTURAL RESEARCH ADMINISTRATION BUREAU OF ANIMAL INDUSTRY ORDER AMENDING REGULATIONS GOVERNING THE PREPARATION, SALE, BARTER, EXCHANGE, SHIPMENT, AND IMPORTATION OF VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS INTENDED FOR USE IN THE TREATMENT OF DOMESTIC ANIMALS Pursuant to the authority conferred upon the Secretary of Agriculture by section 2 of the act of Congress approved February 2. 1903 (32 Stat. 792: 21 U. S. C. Ill), and by the act of Congress approved March 4, 1913 (37 Stat. 832-833; 21 l". S. C. 151-158), and in order better to effectuate the purposes of these acts, Title «>. Chapter I, Subchapter E. Code of Federal Regulations, [B. A. I. Order 276, August 18, 19221, as amended, is hereby further amended effective April 20, 1943, as follows : (1) Section 114.18 [par. 2, Circ. Letter 1796, B. A. I., Sept. 29, 1933 J is amended to read as follows : Sec. 114.18. Scrum and virus; release for marketing. When the last full day for concluding a satisfactory test ends before noon the product, after having been labeled as required by part 112. together with the test animals, may be released after the regular forenoon observations have been made. When the last full day of a tentatively satisfactory test does not end before noon, the product, after having been labeled as required by part 112, may be released after the regular forenoon observations have been made: Provided, That, if, as the result of a careful examination of the test animals by a veterinary inspector at the regular forenoon observation time of the next regular workday, the test is declared unsatisfactory, the manufacturer shall immediately recall all of the product in order that it may be placed under Bureau lock. (2) Section 118.4 [reg. 18, sec. 1, par. 4, B. A. I. Order 276, amdt. 1, Dec. 26, 1922, amdt. 5, Jan. 28, 19291 is amended to read as follows: Sec. 118.4. Virus pigs; inoculation requirements. Pigs for the production of inoculating virus shall weigh not less than 40 pounds nor more than 125 pouuds each and shall be inoculated only with highly virulent hog-cholera virus. No hog-cholera virus shall be used for inoculating pigs for the production of inocu- lating virus, hyperimmunizing virus as prescribed in section 118.15, or simul- taneous virus as prescribed in section 118.17 and for inoculating pigs in serum tests as prescribed in section 119.33 unless it has been produced not more than 60 days prior to use and since completion has been held only in containers of the boro-silicate type or equal of high resistance and low alkalinity and which are properly marked for identification and guaranteed by the manufacturer to be acceptable to the Bureau and to meet the tests developed for determining these qualities. Other virus may be made suitable for inoculation purposes only by passing it through pigs of the same weight and in the same manner as prescribed in section 121.3. Virus derived from these pigs may be used for hyperimmuniza- tlon if the animals react as prescribed in section 118.5. (3) Section 118.7 [reg. 18, sec. 1, par. 7, B. A. I. order 276, Aug. IS. 1922, amdt. 3, Nov. 29. 19241 is amended to read as follows: UL8L7. Pigs that become visibly sick within three days after they have been examined for admission to the premises as prescribed by section 117.9 must be rejected and either shall be destroyed or handled as prescribed by section 117.14. Whenever the third day for observation of pigs falls on a Sunday or a holiday such observation shall be made on the fourth day after admission to the premises, or inoculation. (4) Section 118.37 [reg. 18, sec. 5, par. 3. B. A. I. order 276, amdt 12, May 24, 1935] is amended to read as follows: 118.37. Simultaneous virus; return date. The expiration or return date placed upon the label <>f each immediate or true container of simultaneous virus shall be one of the following: (a) a date within 90 days after the date of manu- facture: Provided, That the simultaneous virus is stored and marketed in con- 524558 r: UNIVERSITY OF FLORIDA III 3 1262 08859 2786 tamers acceptable to the Bureau; (b) a date within 120 days after the date of manufacture when the product is marketed in containers described in section 118.4 and is to be exported to a foreign country and the containers thereof are labeled distinctively. (5) Section 119.4 [reg. 19, sec. 2, par. 2] is amended to read as follows: Sec. 119.4. Hyperimmune hogs; bleedings and times. Anti-hog-cholera serum shall be derived only from hyperimmune hogs which have been subjected to not more than four successive bleedings after each hyperimmunization. The first bleeding shall take place not earlier than 10 days after hyperimmunization, sub- sequent bleedings shall not take place more frequently than once in 7 days, and the last bleeding shall be made on a date not later than 38 days after hyperim- munization : Provided, Final bleeding may be deferred by the Chief of Bureau on special request. These hogs may be bled as aforesaid on any regular working hour of the day of bleeding. However, none shall be passed for food earlier than 10 full days after the time of hyperimmunization. (6) Section 119.33 [reg. 19, sec. 4, par. 11] is amended to read as follows: Sec. 119.33. Serum tests; virus required. Simultaneous virus or its equivalent of high virulence as described in section 118.4 and in sufficient quantities to meet the needs shall be furnished by licensed establishments for use as the inspector in charge may deem advisable for inoculating pigs in serum tests. (7) By amending paragraphs (c) and (d) of section 119.36 [reg. 19, sec. 5, par. 2, rules C and D] to read as follows : (c) Conditions under which to be declared "unsatisfactory for potency." A serum test will be declared "unsatisfactory for potency" when at least two of the control pigs react as described in paragraph (a) and the following conditions obtain : (1) When one or more of the serum-treated pigs become visibly sick subse- quent to the third day after the time of inoculation and fail to fully recover before the test animals are released by a veterinary inspector as provided in this part. (d) Test; conditions under which to be declared' "no test for potency." A serum test will be declared "no test for potency" when any one of the following conditions obtains, but such action will not operate to prevent a retest under the provisions of the regulations in this subchapter : (1) When one or more of the serum-treated pigs become visibly sick on or before the third day after the time of inoculation and fail to recover within the test period. (2) When two or all of the control pigs become visibly sick on or before the third day after the time of inoculation. (3) When two or all of the control pigs do not manifest symptoms of hog cholera as described in paragraph (a). (4) When two or all of the control pigs do not show lesions of hog cholera upon post-mortem examination as described in paragraph (a). (5) When two or all of the control pigs manifest symptoms of hog cholera within seven days as described in paragraph (a) but do not become sick to the degree described in said paragraph. (6) When the serum-treated pigs develop during the test period symptoms of any infectious, contagious, or communicable disease (other than hog cholera) which is not caused by the serum used. (7) When a condition obtains in any of the test pigs which is not otherwise covered in this section. Done at Washington, D. C, this 15th day of April 1943. Witness my hand and the seal of the Department of Agriculture. Claude R. Wickard, Secretary of Agriculture. U. S. GOVERNMENT PRINTING OFFICE: 1943